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Alkylating agents

Immunotherapy + Chemotherapy for Lung Cancer (POSEIDON Trial)

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically documented Stage IV NSCLC
No prior exposure to immunemediated therapy, excluding therapeutic anticancer vaccines
Must not have
Active or prior documented autoimmune or inflammatory disorders
Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing two different ways to treat lung cancer that has spread, one with two immunotherapy drugs and one with just one immunotherapy drug, compared to just using chemotherapy drugs.

Who is the study for?
This trial is for adults with Stage IV non-small cell lung cancer (NSCLC) without certain gene mutations. Participants should be in good physical condition, not have had previous systemic therapy for metastatic NSCLC, and must not have autoimmune diseases, mixed lung cancers, brain metastases unless stable and off steroids, or active infections like TB or hepatitis.
What is being tested?
The study compares three treatments: Durvalumab plus Tremelimumab with standard chemotherapy, Durvalumab with standard chemotherapy alone versus just the standard chemo. It's a Phase III trial to see which combination works best as a first line treatment for advanced lung cancer without specific genetic changes.
What are the potential side effects?
Durvalumab and Tremelimumab can cause immune-related side effects such as inflammation of organs; they may also lead to infusion reactions. Standard chemotherapies can cause nausea, hair loss, fatigue and increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is confirmed to be at stage IV.
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I have never received immune therapy, except for cancer vaccines.
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My tumor's PD-L1 status has been confirmed.
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My cancer does not have EGFR mutations or ALK fusions.
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I am fully active or can carry out light work.
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I have not received any treatment for my advanced lung cancer.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had an autoimmune or inflammatory disorder.
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I do not have active infections like TB, hepatitis B, hepatitis C, or HIV.
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My lung cancer is a mix of small-cell and non-small cell types.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival (OS); D + SoC Compared With SoC Alone
Progression-Free Survival (PFS); D + SoC Compared With SoC Alone
Secondary study objectives
Best Objective Response (BoR)
Duration of Response (DoR)
Number of Patients With ADA Response to Tremelimumab
+9 more
Other study objectives
The safety and tolerability profile of durvalumab +/- tremelimumab in combination with standard of care chemotherapy as determined by adverse events (AEs), physical examninations, laboratory data and vital signs

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Arm 2Experimental Treatment6 Interventions
durvalumab monotherapy + SoC chemotherapy
Group II: Treatment Arm 1Experimental Treatment7 Interventions
durvalumab + tremelimumab combination therapy + SoC chemotherapy
Group III: Treatment Arm 3Active Control5 Interventions
SoC chemotherapy alone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3780
Tremelimumab
2017
Completed Phase 2
~3070

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,378 Previous Clinical Trials
288,737,732 Total Patients Enrolled
Norah Shire, M.D., Ph.D.Study DirectorOne MedImmune Way, Gaithersburg, Maryland 20878, United States
Xiaojin Shi, M.D., MScStudy DirectorOne MedImmune Way, Gaithersburg, Maryland 20878, United States

Media Library

Abraxane + carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03164616 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Treatment Arm 1, Treatment Arm 2, Treatment Arm 3
Non-Small Cell Lung Cancer Clinical Trial 2023: Abraxane + carboplatin Highlights & Side Effects. Trial Name: NCT03164616 — Phase 3
Abraxane + carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03164616 — Phase 3
~142 spots leftby Oct 2025
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